BioSmartData (BSD) has obtained the National Security Framework (ENS) certification in the High category, issued by AENOR, making it one of the first emerging companies in the country to achieve this recognition.
The ENS establishes cybersecurity requirements for systems that manage information in the public sector and in highly regulated environments. Achieving the High category means meeting the most stringent controls on the confidentiality, integrity, and availability of information — a standard that only organizations with the highest level of requirements can meet.
“Our mission is to show that innovation in health and maximum data security are not only compatible, but inseparable. This milestone proves that a startup can meet the highest cybersecurity standards while driving the digital transformation of the healthcare system,” explains María Cayuela, CEO of BioSmartData.
The ENS-2025/0087 certification, valid until 2027, opens the door to collaborations with public administrations, public hospitals, and large hospital groups, as well as international projects where the secure management of sensitive clinical data is critical.
With this recognition, BioSmartData reinforces its commitment to digital security and positions itself as a trusted partner for the collection and analysis of Real-World Evidence (RWE) with Artificial Intelligence — a key technology for personalizing treatments and improving the efficiency of the healthcare system.
Furthermore, this milestone marks another step in BioSmartData’s regulatory strategy, which includes alignment with ISO 27001, MDR, AI Act, and future CE certification as a Software as a Medical Device (SaMD), solidifying the company as a leader in digital health and personalized medicine.
About BioSmartData and the Value of the Certification
BioSmartData has developed a solution for the collection of Real-World Evidence and its analysis using Artificial Intelligence, with the primary goal of placing the patient at the center of medical care, promoting more precise and personalized medicine.
For this reason, the ENS High certification is not just an external recognition: it is a guarantee that the security and protection of patient data and all the systems used daily are safeguarded under the highest national standards.
